WC500169468
WC500169468
WC500169468
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RMP evaluated in the context of PASS results<br />
See also Pioglitazone (ACTOS, GLUSTIN), pioglitazone combinations (COMPETACT, GLUBRAVA,<br />
TANDEMACT) under 3.4.2.<br />
RMP in the context of a renewal of the marketing authorisation, conditional renewal or<br />
annual reassessment<br />
5.2.6. Dronedarone – MULTAQ (CAP)<br />
<br />
Evaluation of an RMP in the context of a 5-renewal of the marketing authorisation<br />
Regulatory details:<br />
PRAC Rapporteur: Menno van der Elst (NL)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/001043/R/0030 (with RMP version 9.0)<br />
MAH(s): Sanofi-aventis groupe<br />
Background<br />
Dronedarone is an antiarrhythmic indicated for the maintenance of sinus rhythm after successful<br />
cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF).<br />
The PRAC is responsible for providing advice to the CHMP on the necessary updates to the RMP in the<br />
context of the 5 year-renewal of the marketing authorisation(s) for Multaq, a centrally authorised<br />
product containing dronedarone.<br />
Summary of advice<br />
<br />
<br />
The updated RMP version 9.0 for Multaq (dronedarone) was considered acceptable.<br />
Based on the review of the available pharmacovigilance data for Multaq and the CHMP<br />
Rapporteur’s assessment report, the PRAC considered that a second five-year renewal of the<br />
marketing authorisation was warranted based on the prior Article 20 referral that restricted the<br />
indication and the implementation of additional risk minimisation measures. This advice is<br />
supported by the need to assess the effectiveness of the risk minimisation measures<br />
implemented.<br />
RMP in the context of a stand-alone RMP procedure<br />
See Annex 14.2<br />
Others<br />
Bisphosphonates, denosumab and risk of osteonecrosis of the jaw (ONJ): consultation with Healthcare<br />
Healthcare Professionals Working Group (HPWG) and Patients and Consumers Working Party (PCWP),<br />
see under 12.12.1.1.<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/324055/2014 Page 32/73
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